Search results for " regulatory" in Articles / App Notes
Article
A Bright Future for the Plasma Fractionation Industry
Among the quality and regulatory trends, Quality-by-Design (QbD) remains to be a popular topic. Philippe Paoloantonnacci presented a QbD approach for a new LFB IVIg product, with identification of Pro…
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Modern Manufacturing Systems Key to FDA Quality Initiative
OPPQ further coordinates FDA quality-related policies with other regulatory authorities and with independent standards-setting organizations.
This approach will be supported by a new quality metri…
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USP Publishes Monoclonal Antibody Guidelines
Applicable requirements for those are determined by the appropriate regulatory agency.
USP reference standard
Accompanying the new general chapter is a recently-developed reference standard (RS…
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FDA Approves First Biosimilar
The decision by the regulatory body comes five years after the passage of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), part of the Affordable Care Act that was signed into law i…
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Ligand-Binding Assays and the Determination of Biosimilarity
He adds that regulatory authorities recommend simple and reliable methods for the characterization of biosimilars, and LBAs are one type of alternative.
For drug substance/drug product testing, on…
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Continued Process Verification for Biopharma Manufacturing
Of course, having and following a CPV plan should also put the manufacturer in more favorable standing with GMP regulatory inspectors.
One of the main struggles to resolve when implementing CPV wi…
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Evaluating Design Margin, Edge of Failure and Process
Movement out of the design space is considered to be a change and would normally initiate a regulatory post-approval change process. Design space is proposed by the applicant and is subject to regulat…
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EMA Invites Comments on New Guidance for Vaccine Development
The new modular guideline is intended to cover and update in one single, consolidated document the existing guidance on regulatory, quality, non-clinical and clinical aspects of the development of all…
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Gowning Practices Provide Clues to cGMP Compliance
This concept is broadly embraced across the globe and promulgated by drug regulatory agencies, such as FDA in the United States, the European Medicines Agency in the European Union, and the World Heal…
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Q&As with Industry Leaders
…nd Efficient Biologic Drug Development
Steven Lynn, Executive Vice-President, Pharmaceuticals, Regulatory Compliance Associates
Future Downstream Process Development So…